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Table 1 Large-scale randomized controlled trials of SGLT2i

From: Cardiovascular benefits of sodium-glucose cotransporter 2 inhibitors in diabetic and nondiabetic patients

Trial name Population(n) CVD (%) T2DM (%) eGFR Intervention Median follow–up (years) Primary outcomes HR (95% CI) HHF
HR
(95% CI) 		DCC
HR
(95%CI) 		DAC
HR
(95%CI) 		FNMI
HR
(95%CI) 		FNS
HR
(95%CI) 		Other outcomes HR/AD (95%CI)
EMPA-REG OUTCOME 7,020 with T2DM and established CVD  > 99 100  ≥ 30 Empagliflozin 10 mg or 25 mg versus placebo 3.1 MACE 0.86 (0.74–0.99) 0.65 (0.50–0.85) 0.62 (0.49–0.77) 0.68 (0.57–0.82) 0.87 (0.70–1.09) 1.18 (0.89–1.56)  
EMPEROR-Reduced 3,730 patients with HFrEF and NYHA class II–IV symptoms 100 50 NA Empagliflozin 10 mg versus placebo 1.3 HHF or DCC 0.75 (0.65–0.86) 0.69 (0.59–0.81) 0.92 (0.75–1.12) 0.92 (0.77–1.10) NA NA Change in KCCQ score 1.7 (0.5–3.0)
CANVAS Program 10,142 patients with T2DM and established CVD or multiple cardiovascular risk factors 66 100  ≥ 30 Canagliflozin 100 mg or 300 mg versus placebo 2.4 MACE 0.86 (0.75–0.97) 0.67 (0.52–0.87) 0.87 (0.72–1.06) 0.87 (0.74–1.01) 0.89 (0.73–1.09) 0.87 (0.69–1.09)  
CREDENCE 4,401 patients with T2DM and albuminuric chronic kidney disease 50 100 30–89 Canagliflozin 100 mg versus placebo 2.6 ESKD, a doubling of serum creatinine level, or renal or cardiovascular death 0.70 (0.59–0.82) 0.61 (0.47–0.80) 0.78 (0.61–1.00) 0.83 (0.68–1.02) NA NA  
DECLARE-TIMI 58 17,160 patients with T2DM and established ASCVD or multiple risk factors for ASCVD 41 100  ≥ 60 Dapagliflozin 10 mg versus placebo 4.2 HHF or DCC 0.83 (0.73–0.95); MACE 0.93 (0.84–1.03) 0.73 (0.61–0.88) 0.98 (0.82–1.17) 0.93 (0.82–1.04) 0.89 (0.77–1.01) 1.01 (0.84–1.21)  
DAPA-HF 4,744 patients with HFrEF and NYHA class II–IV symptoms 100 45  ≥ 30 Dapagliflozin 10 mg versus placebo 1.5 Hospitalization or urgent visit with intravenous therapy for HF or DCC 0.74 (0.65–0.85) 0.70 (0.59–0.83) 0.82 (0.69–0.98) 0.83 (0.71–0.97) NA NA Change in KCCQ score 1.18 (1.11–1.26); DCC or HHF 0.75 (0.65–0.85)
DAPA-CKD 4,304 patients with an eGFR of 25–75 ml/min/1.73m2 and a urinary albumin-to-creatinine ratio of 200–5000 37 68 25–75 Dapagliflozin 10 mg versus placebo 2.4 ESKD, sustained decline in the eGFR of 50%, or renal or cardiovascular death 0.61 (0.51–0.72) NA 0.81 (0.58–1.12) 0.69 (0.53–0.88) NA NA DCC or HHF 0.71 (0.55–0.92)
VERTIS-CV 8,246 patients with T2DM and ASCVD 100 100  ≥ 30 Ertugliflozin 5 mg or 15 mg versus placebo 3.0 MACE 0.97 (0.85–1.11) 0.70 (0.54–0.90) 0.92 (0.77–1.11) 0.93 (0.80–1.08) 1.04 (0.86–1.26) 1.06 (0.82–1.37) DCC or HHF 0.88 (0.75–1.03)
SOLOIST-WHF 1,222 patients with T2DM and hospitalization for worsening heart failure 100 100  ≥ 30 Sotagliflozin 200 mg or 400 mg versus placebo 0.75 Hospitalization or urgent visit for HF or DCC 0.67 (0.52–0.85) 0.64 (0.49–0.83) 0.84 (0.58–1.22) 0.82 (0.59–1.14) NA NA Change in KCCQ score 4.1 (1.3–7.0); Primary outcomes in patients with HFpEF 0.48 (0.27–0.86)
  1. AD absolute difference, ASCVD atherosclerotic cardiovascular disease, CI confidence interval, CVD cardiovascular disease, DAC death from any cause, DCC death from cardiovascular causes, eGFR estimated glomerular filtration rate (ml/min/1.73m2), ESKD end-stage kidney disease, FNMI non-fatal or fatal myocardial infarction, FNS non-fatal or fatal stroke, HHF hospitalization for heart failure, HF heart failure, HFpEF heart failure with preserved ejection fraction, HFrEF heart failure with reduced ejection fraction, HR hazard ratio, KCCQ Kansas City Cardiomyopathy Questionnaire, MACE major adverse cardiovascular events (death from cardiovascular causes, non-fatal myocardial infarction, and non-fatal stroke), NA not available, NYHA New York Heart Association, SGLT2 sodium-glucose cotransporter 2, T2DM type 2 diabetes mellitus
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Cardiovascular Diabetology

ISSN: 1475-2840

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